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临床试验/NCT01933646
NCT01933646已完成不适用

Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China: Incidence, Case Fatality Rate and Serotype Distribution

Novartis Vaccines3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年9月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
3
主要终点
Case Fatality Rate of GBS disease
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 90 Days（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Positive culture for GBS from one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain).
  • •≤90 days old at the time of GBS confirmation.
  • •Voluntary written informed consent provided.

排除标准

  • 未提供

结局指标

主要结局

Case Fatality Rate of GBS disease

时间窗: From birth to 90 days of age

Incidence of group B streptococcal (GBS) disease

时间窗: From birth to 90 days of age

GBS serotype distribution

时间窗: From birth to 90 days of age

次要结局

未报告次要终点

研究者

发起方
Novartis Vaccines
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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